Quality indicators for the processing of health products: A mixed-methods study.

OBJECTIVE: to analyze the use of quality assessment indicators and their implementation to improve quality in the processing of health products. METHOD: a mixed-methods study with a multiple case approach using Structure, Process and Results indicators and elaboration of a plan using Appreciative Inquiry, carried out in four central sterile supply departments from hospital units. RESULTS: the indicators for the Cleaning stage presented 47.8% compliance for Structure and 59.0% for Process: in addition 71.8% of the products were clean. In the Preparation operational stage, 50.0% of the Results indicators were in compliance for Structure and 66.7% for Process. In the Sterilization, Storage and Distribution stage, 43.5% compliance was obtained for Structure, 55.7% for Process and 78.6% for Packaging conservation. Appreciative planning proposed improvements to the physical structure, review of processes and protocols, promotion and appreciation of the work done and strengthening of teaching about processing and service management, highlighting the protagonism of the group and of the leaders. CONCLUSION: using indicators was positive in materializing reality; however, it was verified that the improvements proposed are related to people. The affirmative and constructive view of Appreciative Inquiry presented itself as a path to changes and quality improvements.

Quality indicators for the processing of health products: A mixed-methods study / Indicadores de calidad para el procesamiento de productos para la salud: estudio de método mixto / Indicadores de qualidade para o processamento de produtos para saúde: estudo de método misto

Objective: to analyze the use of quality assessment indicators and their implementation to improve quality in the processing of health products. Method: a mixed-methods study with a multiple case approach using Structure, Process and Results indicators and elaboration of a plan using Appreciative Inquiry, carried out in four central sterile supply departments from hospital units. Results: the indicators for the Cleaning stage presented 47.8% compliance for Structure and 59.0% for Process: in addition 71.8% of the products were clean. In the Preparation operational stage, 50.0% of the Results indicators were in compliance for Structure and 66.7% for Process. In the Sterilization, Storage and Distribution stage, 43.5% compliance was obtained for Structure, 55.7% for Process and 78.6% for Packaging conservation. Appreciative planning proposed improvements to the physical structure, review of processes and protocols, promotion and appreciation of the work done and strengthening of teaching about processing and service management, highlighting the protagonism of the group and of the leaders. Conclusion: using indicators was positive in materializing reality; however, it was verified that the improvements proposed are related to people. The affirmative and constructive view of Appreciative Inquiry presented itself as a path to changes and quality improvements.

Objetivo: analizar el uso y la implementación de indicadores de evaluación de la calidad para mejorar la calidad del procesamiento de productos para la salud. Método: estudio mixto, con enfoque de casos múltiples que usa indicadores de estructura, proceso y resultado y la elaboración de una planificación mediante la investigación apreciativa, realizado en cuatro centros de material y esterilización de unidades hospitalarias. Resultados: los indicadores de la etapa de limpieza mostraron un 47,8% de conformidad en estructura, un 59,0% en proceso y el 71,8% de los productos estaban limpios. En la etapa operativa de la preparación, se registró conformidad en el 50,0% de los indicadores de resultados de estructura y en el 66,7% de proceso. En la etapa de esterilización, almacenamiento y distribución se obtuvo un 43,5% de conformidad en estructura, un 55,7% en proceso y un 78,6% en conservación de los envases. La planificación apreciativa propuso mejoras para la estructura física, revisión de procesos y protocolos, promoción y valoración del trabajo, fortalecimiento de la enseñanza sobre procesamiento y gestión de servicios, y destacó el protagonismo del grupo y del liderazgo. Conclusión: el uso de indicadores fue positivo para materializar la realidad, sin embargo, se observó que las mejoras propuestas tienen que ver con las personas. La visión afirmativa y constructiva de la investigación apreciativa demostró ser útil para cambiar y mejorar la calidad.

Objetivo: analisar o uso de indicadores de avaliação da qualidade e suas implementações para melhoria da qualidade do processamento de produtos para saúde. Método: estudo misto, com abordagem de casos múltiplos utilizando indicadores de estrutura, processo e resultado e a construção de um planejamento utilizando a investigação apreciativa, realizado em quatro centros de material e esterilização de unidades hospitalares. Resultados: os indicadores para a etapa da limpeza apresentaram 47,8% de conformidade para estrutura, 59,0% para processo e 71,8% de produtos estavam limpos. Na etapa operacional do preparo, 50,0% dos indicadores de resultados estiveram em conformidade para estrutura e 66,7%, para processo. Na etapa de esterilização, armazenamento e distribuição, obtiveram-se 43,5% de conformidade para estrutura, 55,7% para processo e 78,6% para conservação das embalagens. O planejamento apreciativo propôs melhorias para a estrutura física, revisão de processos e protocolos, promoção e valorização do trabalho, fortalecimento do ensino sobre processamento e a gerência do serviço, destacando o protagonismo do grupo e da liderança. Conclusão: o uso dos indicadores foi positivo na materialização da realidade, porém verificou-se que as melhorias propostas se relacionam às pessoas. A visão afirmativa e construtiva da investigação apreciativa apresentou-se como caminho para mudanças e melhorias da qualidade.

Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial.

Importance: The effectiveness of goal-directed care to reduce loss of brain-dead potential donors to cardiac arrest is unclear. Objective: To evaluate the effectiveness of an evidence-based, goal-directed checklist in the clinical management of brain-dead potential donors in the intensive care unit (ICU). Design, Setting, and Participants: The Donation Network to Optimize Organ Recovery Study (DONORS) was an open-label, parallel-group cluster randomized clinical trial in Brazil. Enrollment and follow-up were conducted from June 20, 2017, to November 30, 2019. Hospital ICUs that reported 10 or more brain deaths in the previous 2 years were included. Consecutive brain-dead potential donors in the ICU aged 14 to 90 years with a condition consistent with brain death after the first clinical examination were enrolled. Participants were randomized to either the intervention group or the control group. The intention-to-treat data analysis was conducted from June 15 to August 30, 2020. Interventions: Hospital staff in the intervention group were instructed to administer to brain-dead potential donors in the intervention group an evidence-based checklist with 13 clinical goals and 14 corresponding actions to guide care, every 6 hours, from study enrollment to organ retrieval. The control group provided or received usual care. Main Outcomes and Measures: The primary outcome was loss of brain-dead potential donors to cardiac arrest at the individual level. A prespecified sensitivity analysis assessed the effect of adherence to the checklist in the intervention group. Results: Among the 1771 brain-dead potential donors screened in 63 hospitals, 1535 were included. These patients included 673 males (59.2%) and had a median (IQR) age of 51 (36.3-62.0) years. The main cause of brain injury was stroke (877 [57.1%]), followed by trauma (485 [31.6%]). Of the 63 hospitals, 31 (49.2%) were assigned to the intervention group (743 [48.4%] brain-dead potential donors) and 32 (50.8%) to the control group (792 [51.6%] brain-dead potential donors). Seventy potential donors (9.4%) at intervention hospitals and 117 (14.8%) at control hospitals met the primary outcome (risk ratio [RR], 0.70; 95% CI, 0.46-1.08; P = .11). The primary outcome rate was lower in those with adherence higher than 79.0% than in the control group (5.3% vs 14.8%; RR, 0.41; 95% CI, 0.22-0.78; P = .006). Conclusions and Relevance: This cluster randomized clinical trial was inconclusive in determining whether the overall use of an evidence-based, goal-directed checklist reduced brain-dead potential donor loss to cardiac arrest. The findings suggest that use of such a checklist has limited effectiveness without adherence to the actions recommended in this checklist. Trial Registration: ClinicalTrials.gov Identifier: NCT03179020.

Fatores de risco para infecções relacionadas à assistência à saúde em unidades de terapia intensiva / Risk factors for healthcare-associated infections in intensive care units

Objetivo: Investigar os fatores de risco para infecções relacionadas à assistência entre pacientes internados em uma Unidade de Terapia Intensiva de uma capital do Norte do Brasil. Métodos: Estudo de coorte prospectiva, com 267 pacientes internados no período de 01 de outubro de 2017 a 30 de janeiro 2019. As informações foram coletadas de prontuário eletrônico, físico e padrão de acompanhamento dos pacientes. Investigaram-se informações demográficas sobre a internação e tratamento. Realizada regressão de Poisson para avaliação das variáveis com o desfecho. Resultados: A incidência de infecções foi de 10,49 casos por 100 pacientes, com a maior frequência para infecção de sítio cirúrgico. Na análise ajustada, internação por mais de cinco dias (RR: 6,98; IC95%: 1,42; 34,15), parada cardiorrespiratória (RR: 2,89; IC95%:1,05;7,96), ter ostomia (RR: 9,22; IC95%:1,47; 57,65) ou traqueostomia (RR: 10,23; IC95%: 1,56;67,22) foram associados às infecções relacionadas à assistência. Conclusão: A incidência de infecções encontrada foi superior às outras regiões brasileiras. Recomenda-se vigilância ativa, principalmente em pacientes com internação prolongada e ostomias, avaliação criteriosa da necessidade de dispositivos e uso de protocolos para adoção de boas práticas. Descritores: Infecção Hospitalar; Unidades de Terapia Intensiva; Segurança do Paciente.

Objective: To investigate the risk factors for infections related to care among patients hospitalized in an Intensive Care Unit in a capital in northern Brazil. Methods: A prospective cohort study, with 267 patients hospitalized from October 1, 2017 to January 30, 2019. Information was collected from electronic and physical medical records and patients' follow-up pattern. Information was collected from electronic and physical medical records and patients' follow-up pattern. Demographic information about hospitalization and treatment was investigated. Poisson regression was performed to assess the variables with the outcome. Results: Infection incidence was 10.49 cases per 100 patients, with the highest frequency for surgical site infection. In the adjusted analysis, hospitalization for more than five days (RR: 6.98; 95%CI: 1.42; 34.15), cardiopulmonary arrest (RR: 2.89; 95%CI:1.05;7.96), having an ostomy (RR: 9.22; 95%CI:1.47; 57.65) or tracheostomy (RR: 10.23; 95%CI: 1.56;67.22) were associated with healthcare-associated infections. Conclusion: The incidence of infections found was higher than in other Brazilian regions. Active surveillance is recommended, especially in patients with prolonged hospitalization and ostomy, careful assessment of the need for devices and use of protocols for the adoption of good practices. Descriptors: Cross Infection; Intensive Care Units; Patient Safety.

Interventions to Improve the Quality in the Organ and Tissue Donation Process.

BACKGROUND: Map Interventions is capable of supporting the multidisciplinary team that works in organ and tissue donation to disseminate quality in this process. METHODS: A scoping review study that was conducted through the steps proposed by the Joanna Briggs Institute. RESULTS: Fifty-six studies made up the sample. 2018 (no. 07, 12.5%) had the highest number of publications. The country that published the most was the United States (no. 16, 28.56%). The database with the most publications was the Cumulative Index to Nursing and Allied Health Literature - CINAHL (no. 15, 26.78%). The most used interventions, which had the most significant impact on the improvement of results and quality, were the use of indicators in all stages of the organ and tissue donation process; the use of real goals that can be achieved; frequent audits, validation of instruments to track opportunities for improvement; as well as methodologies to implement quality and education among professionals who work in this process. Such interventions reveal important changes in the organ donation process, especially in the notification of potential and effective donors, as well as providing an opportunity for safety in the stages of the organ and tissue donation process. CONCLUSION: The interventions tracked suggest the implementation of a set of actions formed by the continuous use of auditing, indicators, continuing education with the team that works in the process of organ and tissue donation, combined with the management of the results obtained through the indicators, where it is generated from these data, actions that have a direct impact on the weaknesses identified.

Adenosine triphosphate (ATP) sampling algorithm for monitoring the cleanliness of surgical instruments.

BACKGROUND: Timely detection of cleaning failure is critical for quality assurance within Sterilising Service Units (SSUs). Rapid Adenosine Triphosphate (ATP) testing provides a real time and quantitative indication of cellular contaminants, when used to measure surface or device cleanliness. The aim of this study was to investigate the use of an ATP algorithm and to whether it could be used as a routine quality assurance step, to monitor surgical instruments cleanliness in SSUs prior to sterilisation. METHODS: Cleanliness monitoring using rapid ATP testing was undertaken in the SSUs of four hospitals located in the western (Amazonia) region of Brazil. ATP testing was conducted (Clean Trace, 3M) on 163 surgical instruments, following manual cleaning. A sampling algorithm using a duplicate swab approach was applied to indicate surgical instruments as (i) very clean, (ii) clean, (iii) equivocal or (iv) fail, based around a 'clean' cut-off of 250 Relative Light Units (RLU) and a 'very clean' <100 RLU. RESULTS: The four cleanliness categories were significantly differentiated (P≤0.001). The worst performing locations (hospitals A & C) had failure rates of 39.2% and 32.4%, respectively, and were distinctly different from hospitals B & D (P≤0.001). The best performing hospitals (B & D) had failure rates of 7.7% and 2.8%, respectively. CONCLUSION: The ATP testing algorithm provides a simple to use method within SSUs. The measurements are in real time, quantitative and useful for risk-based quality assurance monitoring, and the tool can be used for staff training. The four-tiered approach to the grading of surgical instrument cleanliness provides a nuanced approach for continuous quality improvement within SSU than does a simple pass/fail methodology.

Organ and Tissue Donation Consent Model and Intent to Donate Registries: Recommendations From an International Consensus Forum.

Consent model and intent to donate registries are often the most public facing aspects of an organ and tissue donation and transplantation (OTDT) system. This article describes the output of an international consensus forum designed to give guidance to stakeholders considering reform of these aspects of their system. Methods: This Forum was initiated by Transplant Québec and cohosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This article describes the output of the consent and registries domain working group, which is 1 of 7 domains from this Forum. The domain working group members included administrative, clinical, and academic experts in deceased donation consent models in addition to 2 patient, family, and donor partners. Topic identification and recommendation consensus was completed over a series of virtual meetings from March to September 2021. Consensus was achieved by applying the nominal group technique informed by literature reviews performed by working group members. Results: Eleven recommendations were generated and divided into 3 topic groupings: consent model, intent to donate registry structure, and consent model change management. The recommendations emphasized the need to adapt all 3 elements to the legal, societal, and economic realities of the jurisdiction of the OTDT system. The recommendations stress the importance of consistency within the system to ensure that societal values such as autonomy and social cohesion are applied through all levels of the consent process. Conclusions: We did not recommend one consent model as universally superior to others, although considerations of factors that contribute to the successful deployment of consent models were discussed in detail. We also include recommendations on how to navigate changes in the consent model in a way that preserves an OTDT system's most valuable resource: public trust.

Conhecimento dos profissionais da atenção primária à saude sobre segurança do paciente em Rondônia / Knowledge of primary health care professionals about patient safety in Rondônia / Conocimiento de los profesionales de atención primaria de salud sobre la seguridad del paciente en Rondônia

INTRODUÇÃO: O programa de Segurança do Paciente tem como principal objetivo a redução a um nível mínimo aceitável do risco de danos evitáveis associados à assistência em saúde. Visando qualificar esse cuidado na Atenção Primária à Saúde (APS), o Conselho Nacional de Secretários de Saúde tem desenvolvido a Planificação da Atenção à Saúde (PAS) com apoio de instituições de excelência e secretarias de saúde. OBJETIVO: Identificar o conhecimento dos profissionais da Atenção Primária à Saúde envolvidos na planificação acerca da segurança do paciente em Rondônia. MÉTODO: Estudo transversal conduzido no estado de Rondônia com profissionais e estudantes envolvidos na PAS que estiveram em um evento estadual nos dias 24 a 26 de agosto de 2022. A coleta de dados foi realizada por meio de formulário eletrônico em link e os dados foram analisados por meio do pacote estatístico Stata versão16. Este estudo faz parte do projeto matriz intitulado: Boas Práticas na Assistência ao Paciente, no Controle da Infecção e no Processamento de Produtos para a Saúde no Estado de Rondônia autorizado através do parecer número 3.771.377. RESULTADOS E DISCUSSÃO: Do total de 160 participantes do evento, 90 indivíduos aceitaram participar deste estudo. Entre os achados, constatou-se 80,7% de conhecimento geral sobre o tema, sendo que mais de 75% dos participantes apresentaram conhecimento sobre os conceitos de segurança do paciente e quase 68% avaliaram corretamente as situações de segurança do paciente na APS. O menor nível de conhecimento foi referente às situações específicas. CONCLUSÃO: Esse estudo contribui para um diagnóstico situacional do conhecimento dos trabalhadores da APS que participam do projeto de PAS no estado de Rondônia, podendo ser utilizado para o planejamento de outras ações educativas com a temática de segurança do paciente neste estado e em outros com o mesmo perfil dos trabalhadores e organização dos serviços de saúde.

INTRODUCTION: The main objective of the Patient Safety program is to reduce the risk of avoidable harm associated with health care to an acceptable minimum level. Aiming to qualify this care in Primary Health Care (PHC), the National Council of Health Secretaries has developed the Health Care Plan (PAS) with the support of institutions of excellence and health secretariats. OBJECTIVE: To identify the knowledge of Primary Health Care professionals involved in planning about patient safety in Rondônia. METHOD: Cross-sectional study conducted in the state of Rondônia with professionals and students involved in the PAS who attended a state event from August 24 to 26, 2022. Data collection was performed using an electronic form in the link and the data were analyzed using the statistical package Stata version16. This study is part of the matrix project entitled: Good Practices in Patient Care, Infection Control and Processing of Health Products in the State of Rondônia authorized through opinion number 3,771,377. RESULTS AND DISCUSSION: Of the total of 160 participants in the event, 90 individuals agreed to participate in this study. Among the findings, there was 80.7% of general knowledge on the subject, with more than 75% of the participants having knowledge about patient safety concepts and almost 68% correctly assessing patient safety situations in PHC. The lowest level of knowledge was related to specific situations. CONCLUSION: This study contributes to a situational diagnosis of the knowledge of PHC workers who participate in the PAS project in the state of Rondônia, and can be used for the planning of other educational activities with the subject of patient safety in this state and in others with the aim of same profile of workers and organization of health services.

INTRODUCCIÓN: El objetivo principal del programa de Seguridad del Paciente es reducir el riesgo de daño evitable asociado con la atención médica a un nivel mínimo aceptable. Con el objetivo de calificar este cuidado en la Atención Primaria de Salud (APS), el Consejo Nacional de Secretarías de Salud ha desarrollado el Plan de Atención a la Salud (PAS) con el apoyo de instituciones de excelencia y secretarías de salud. OBJETIVO: Identificar el conocimiento de los profesionales de la Atención Primaria de Salud involucrados en la planificación sobre la seguridad del paciente en Rondônia. MÉTODO: Estudio transversal realizado en el estado de Rondônia con profesionales y estudiantes involucrados en el PAS que asistieron a un evento estatal del 24 al 26 de agosto de 2022. La recolección de datos se realizó mediante un formulario electrónico en el enlace y los datos fueron analizados. utilizando el paquete estadístico Stata versión16. Este estudio forma parte del proyecto matriz titulado: Buenas Prácticas en Atención al Paciente, Control de Infecciones y Procesamiento de Productos de Salud en el Estado de Rondônia autorizado por dictamen número 3.771.377. RESULTADOS Y DISCUSIÓN: Del total de 160 participantes en el evento, 90 personas aceptaron participar en este estudio. Entre los hallazgos, se encontró un 80,7% de conocimientos generales sobre el tema, siendo más del 75% de los participantes con conocimientos sobre conceptos de seguridad del paciente y casi el 68% valorando correctamente situaciones de seguridad del paciente en la APS. El nivel más bajo de conocimiento estaba relacionado con situaciones específicas. CONCLUSIÓN: Este estudio contribuye para un diagnóstico situacional del conocimiento de los trabajadores de la APS que participan del proyecto PAS en el estado de Rondônia, y puede ser utilizado para la planificación de otras actividades educativas con el tema de seguridad del paciente en este estado y en otros con el objetivo de igualar el perfil de los trabajadores y la organización de los servicios de salud.

Impact of the COVID-19 Pandemic on Solid Organ Transplant and Rejection Episodes in Brazil's Unified Healthcare System.

BACKGROUND: Brazil has the world's largest public organ transplant program, which was severely affected by the COVID-19 pandemic. The primary aim of the study was to evaluate differences in solid organ transplants and rejection episodes during the COVID-19 pandemic compared to the five years before the pandemic in the country. METHODS: A seven-year database was built by downloading data from the DATASUS server. The pandemic period was defined as March 2020 to December 2021. The pre-pandemic period was from January 2015 to March 2020. RESULTS: During the pandemic, the number of solid organ transplants decreased by 19.3% in 2020 and 22.6% in 2021 compared to 2019. We found a decrease for each evaluated organ, which was more pronounced for lung, pancreas, and kidney transplants. The seasonal plot of rejection data indicated a high rejection rate between 2018 and 2021. There was also an 18% (IRR 1.18 (95% CI 1.01 to 1.37), p = 0.04) increase in the rejection rate during the COVID-19 pandemic. CONCLUSIONS: The total number of organ transplants performed in 2021 represents a setback of six years. Transplant procedures were concentrated in the Southeast region of the country, and a higher proportion of rejections occurred during the pandemic. Together, these findings could have an impact on transplant procedures and outcomes in Brazil.

Processamento de produtos odontológicos em unidades básicas de saúde na cidade de Porto Velho, Rondônia / Processing of dental products in basic health units of Porto Velho, Rondônia

Avaliar o processamento de produtos odontológicos em unidades básicas de saúde na cidade de Porto Velho, capital de Rondônia. Estudo transversal conduzido em 13 unidades com coleta em três etapas: preenchimento de questionário, observação não participante e leitura de registros. A conformidade no processamento dos produtos foi avaliada de acordo com as recomendações e normativas vigentes no Brasil. Pouco mais da metade das unidades apresenta sala de expurgo exclusiva (53,8%) e havia inconformidades relacionadas à iluminação (69,3%), água potável (100,0%) e falta de escovas adequadas (46,2%). Todas as unidades ofereciam equipamento de proteção individual. Apenas 18,6% utilizavam detergentes adequados ou sabão desincrustante e 100,0% dos produtos eram lavados manualmente. As principais inconformidades foram o uso de material abrasivo (46,2%), não utilização de óculos ou máscaras (100,0%), inspeção incorreta após a lavagem (100,0%), preparo inadequado de soluções de desinfecção química (77,0%) e 84,6% não realizavam o enxágue adequado. O processamento de produtos odontológicos na atenção básica de saúde na cidade de Porto Velho apresenta fragilidades que podem levar a infecções relacionadas à assistência à saúde.

To evaluate the processing of dental products in basic health units in the capital of Rondônia. Cross-sectional study conducted in 13 units with collection in three stages: filling out a questionnaire, non-participant observation and reading of records. Compliance in the processing of products was evaluated in accordance with the recommendations and regulations in force in Brazil. Just over half of the units have an exclusive purge room (53.8%) and there were nonconformities related to lighting (69.3%), potable water (100%) and lack of adequate brushes (46.2%). All units offered personal protective equipment. Only 18.6% used adequate detergents or descaling soap and 100.0% of the products were washed manually. The main nonconformities were the use of abrasive material (46.2%), non-use of glasses or masks (100.0%), non-correct inspection after washing (100.0%), inadequate preparation of chemical disinfection solutions (77.0%) and 84.6% did not rinse with abundant water. The processing of dental products in in primary care in Porto Velho has weaknesses that can lead to infections related to health care.

Fatores de risco nas neurocirurgias: um estudo de coorte no norte do Brasil / Risk factors in neurosurgery: a cohort study in northern Brazil

Introdução: Pacientes neurocirúrgicos apresentam elevado risco de complicações locais e sistêmicas que podem aumentar o tempo de internação e o risco de morte. Este estudo tem como objetivo avaliar a incidência de infecções relacionadas à assistência à saúde e os fatores de risco associados em pacientes submetidos às neurocirurgias. Materiais e métodos: Estudo de coorte prospectiva, realizado em um Hospital de grande porte do estado de Rondônia, no período de 2018 a 2019, incluindo 36 pacientes. Resultados: A incidência de infecções relacionada à assistência à saúde foi 19,4 a cada 100 pacientes (IC95%: 8,19 ­ 36,02). Ter utilizado sonda nasoenteral aumentou em 6,5 vezes o risco de IRAS (IC 95%: 1,26 ­ 33,5), a ventilação mecânica aumentou 5,52 vezes o risco (IC95%: 1,23 ­ 24,6), a presença de traqueostomia aumentou seis vezes (IC95%: 1,34 ­ 26,8) e realização de exame invasivo aumentou o risco em 6,79 para ter infecção (IC95%: 1,31 ­ 35,05). Na análise ajustada as variáveis não apresentaram significância estatística. Discussão: A incidência de infecções foi maior do que em regiões com melhores condições socioeconômicas o que pode estar relacionado à menor adesão de boas práticas na assistência. Conclusão: Nas neurocirurgias além das infecções de sítio cirúrgico outras topografias também devem ser consideradas para investigação de infecção. O uso de dispositivos invasivos foi associado à ocorrência de infecções relacionadas à assistência à saúde, portanto as boas práticas no seu uso são essenciais no momento da indicação e uso destes dispositivos.

Introduction: Neurosurgical patients are at high risk of local and systemic complications that can increase the length of hospital stay and the risk of death. This study aims to assess the incidence of healthcare-associated infections and associated risk factors in patients undergoing neurosurgery. y. Materials and Methods:: Prospective cohort study, carried out in a large hospital in the state of Rondônia, from 2018 to 2019, including 36 patients. Results:The incidence of healthcare-associated infections was 19.4 per 100 patients (95%CI: 8.19 ­ 36.02). Having used a nasoenteral tube increased the risk of HAI by 6.5 times (95% CI: 1.26 ­ 33.5), mechanical ventilation increased the risk by 5.52 times (95% CI: 1.23 ­ 24.6) , the presence of tracheostomy increased six-fold (95%CI: 1.34 ­ 26.8) and performing an invasive examination increased the risk of infection by 6.79 (95%CI: 1.31 ­ 35.05). In the adjusted analysis, the variables did not show statistical significance. Discussion:The incidence of infections was higher than in regions with better socioeconomic conditions, which may be related to lower adherence to good care practices. Conclusions: : In neurosurgery, in addition to surgical site infections, other topographies should also be considered for the investigation of infection. The use of invasive devices was associated with the occurrence of infections related to health care, so good practices in their use are essential when indicating and using these devices.

Introducción:Los pacientes neuroquirúrgicos tienen un alto riesgo de complicaciones locales y sistémicas que pueden aumentar la estancia hospitalaria y el riesgo de muerte. Este estudio tiene como objetivo evaluar la incidencia de infecciones asociadas a la atención médica y los factores de riesgo asociados en pacientes sometidos a neurocirugía. Materiales y métodos: : Estudio de cohorte prospectivo, realizado en un gran hospital del estado de Rondônia, de 2018 a 2019, con 36 pacientes. Resultados: La incidencia de infecciones asociadas a la asistencia sanitaria fue de 19,4 por 100 pacientes (IC95%: 8,19 ­ 36,02). Haber utilizado una sonda nasoenteral aumentó el riesgo de IRAS en 6,5 veces (IC 95%: 1,26 ­ 33,5), la ventilación mecánica aumentó el riesgo en 5,52 veces (IC 95%: 1,23 ­ 24,6), la presencia de traqueotomía aumentó seis veces (IC95%: 1,34 ­ 26,8) y realizar un examen invasivo aumentó el riesgo de infección en 6,79 (IC95%: 1,31 ­ 35,05). En el análisis ajustado, las variables no presentaron significación estadística. Discusión: La incidencia de infecciones fue mayor que en las regiones con mejores condiciones socioeconómicas, lo que puede estar relacionado con una menor adherencia a las buenas prácticas de cuidado. Conclusión: En neurocirugía, además de las infecciones del sitio quirúrgico, también se deben considerar otras topografías para la investigación de la infección. El uso de dispositivos invasivos se asoció con la ocurrencia de infecciones relacionadas con el cuidado de la salud, por lo que las buenas prácticas en su uso son fundamentales a la hora de indicar y utilizar estos dispositivos

Cultura de segurança do paciente em maternidade da Amazônia Ocidental / Culture of patient safety in maternity in the western amazon / Cultura de seguridad del paciente en maternidad en la amazonia occidental

Objetivo: analisar a cultura de segurança do paciente entre os profissionais de saúde de maternidade pública da Região Norte do Brasil. Método: estudo transversal, realizado em 2019, com 70 profissionais atuantes na gestão ou assistência à saúde. Analisaram-se 12 dimensões da cultura de segurança do paciente, por meio do questionário Hospital Survey on Patient Safety Culture. Procedeu-se à análise descritiva e aplicou-se o teste Qui-quadrado de Pearson para verificar associação estatística entre as variáveis do estudo. Resultados: a maioria dos participantes era do sexo feminino, média de idade 39 anos e com cursos de pós-graduação. Na avaliação das 12 dimensões da cultura de segurança do paciente, verificou-se uma área de fortaleza com mais de 75% de respostas positivas ­ "Expectativas e ações do supervisor/chefe para a promoção da segurança do paciente". Houve diferença estatisticamente significativa entre o tempo de trabalho na instituição e o modo com que o participante qualificou a segurança do paciente. Conclusão: substituir a cultura punitiva pelo aprendizado com os erros e estimular a comunicação interprofissional são ações que podem ser trabalhadas pelo serviço na busca de uma cultura positiva. Descritores: Estudos transversais; Segurança do Paciente; Cultura organizacional; Saúde materno-infantil; Maternidades; Profissionais de saúde.(AU)

Objective: to analyze the patient safety culture among health professionals in a public maternity hospital in the North region of Brazil. Method: cross-sectional study, conducted in 2019 with 70 professionals working in management or health care. The 12 dimensions of patient safety culture were analyzed using the Hospital Survey on Patient Safety Culture questionnaire. Descriptive analysis and Pearson's chi-square test were performed to verify statistical association among the study variables. Results: most participants were female, mean age of 39 years and had postgraduate degrees. In the evaluation of the 12 dimensions of Patient Safety Culture there was only one area of strength with more than 75% of positive answers - "Expectations and actions of the supervisor/chief for the promotion of patient safety". There was a statistically significant difference between the length of time working at the institution and the way this participant rated patient safety. Conclusion: replacing the punitive culture by learning from mistakes and stimulating interprofessional communication are actions that can be worked on by the service in the search for a positive culture.(AU)

Objetivo: analizar la cultura de seguridad del paciente entre los profesionales de la salud en una maternidad pública de la región Norte de Brasil. Método: estudio transversal realizado en 2019 con 70 profesionales que trabajan en la gestión de la salud o en la atención sanitaria. Las 12 dimensiones de la cultura de seguridad del paciente se analizaron mediante el cuestionario Hospital Survey on Patient Safety Culture. Se realizó un análisis descriptivo y la prueba de Chi-cuadrado de Pearson para verificar la asociación estadística entre las variables del estudio. Resultados: la mayoría de los participantes eran mujeres, tenían una edad media de 39 años y contaban con títulos de postgrado. En la evaluación de las 12 dimensiones de la Cultura de Seguridad del Paciente se verificó sólo un área de fortaleza con más del 75% de respuestas positivas - "Expectativas y acciones del supervisor/jefe para la promoción de la seguridad del paciente". Hubo una diferencia estadísticamente significativa entre el tiempo de trabajo en la institución y la forma en que este participante calificó la seguridad del paciente. Conclusión: reemplazar la cultura punitiva por el aprendizaje de los errores y estimular la comunicación interprofesional son acciones que pueden ser trabajadas por el servicio en la búsqueda de una cultura positiva.(AU)

Brazilian guidelines for the management of brain-dead potential organ donors. The task force of the Associação de Medicina Intensiva Brasileira, Associação Brasileira de Transplantes de Órgãos, Brazilian Research in Critical Care Network, and the General Coordination of the National Transplant System. / Diretrizes brasileiras para o manejo de potenciais doadores de órgãos em morte encefálica. Uma força-tarefa composta por Associação de Medicina Intensiva Brasileira, Associação Brasileira de Transplantes de Órgãos, Brazilian Research in Critical Care Network e Coordenação Geral do Sistema Nacional de Transplantes.

OBJECTIVE: To contribute to updating the recommendations for brain-dead potential organ donor management. METHODS: A group of 27 experts, including intensivists, transplant coordinators, transplant surgeons, and epidemiologists, answered questions related to the following topics were divided into mechanical ventilation, hemodynamics, endocrine-metabolic management, infection, body temperature, blood transfusion, and checklists use. The outcomes considered were cardiac arrests, number of organs removed or transplanted as well as function / survival of transplanted organs. The quality of evidence of the recommendations was assessed using the Grading of Recommendations Assessment, Development, and Evaluation system to classify the recommendations. RESULTS: A total of 19 recommendations were drawn from the expert panel. Of these, 7 were classified as strong, 11 as weak and 1 was considered a good clinical practice. CONCLUSION: Despite the agreement among panel members on most recommendations, the grade of recommendation was mostly weak.

OBJETIVO: Fornecer recomendações para nortear o manejo clínico do potencial doador em morte encefálica. MÉTODOS: O presente documento foi formulado em dois painéis compostos por uma força tarefa integrada por 27 especialistas de diferentes áreas que responderam a questões dirigidas aos seguintes temas: ventilação mecânica, hemodinâmica, suporte endócrino-metabólico, infecção, temperatura corporal, transfusão sanguínea, e uso de checklists. Os desfechos considerados foram: parada cardíaca, número de órgãos retirados ou transplantados e função/sobrevida dos órgãos transplantados. A qualidade das evidências das recomendações foi avaliada pelo sistema Grading of Recommendations Assessment, Development, and Evaluation. RESULTADOS: Foram geradas 19 recomendações a partir do painel de especialistas. Dessas, 7 foram classificadas como fortes, 11 fracas e uma foi considerada boa prática clínica. CONCLUSÃO: Apesar da concordância entre os membros do painel em relação à maior parte das recomendações, o grau de recomendação é fraco em sua maioria.

Avaliação dos riscos psicossociais no centro de material e esterilização do norte do Brasil / Evaluation of psychosocial risks in the central sterile supply department of northern Brazil / Evaluación de riesgos psicosociales en el centro de material y esterilización del norte de Brasil

Objetivo: Analisar o nível de riscos psicossociais dos trabalhadores do Centro de Material e Esterilização de um hospital de grande porte de Rondônia. Método: Estudo transversal, incluindo auxiliares, técnicos de enfermagem e enfermeiros, utilizando o questionário Copenhagen Psychosocial Questionnaire. As análises descritivas foram realizadas no pacote estatístico Stata® versão 11. Resultados: Participaram 35 trabalhadores, sendo a maioria mulheres, com idade acima de 40 anos e técnicas de enfermagem. Das seis dimensões avaliadas, quatro tiveram risco médio. A dimensão sobre justiça e respeito apresentou elevado risco psicossocial, e a dimensão organização do trabalho e conteúdo, baixo risco. Conclusão: Os trabalhadores consideravam seu trabalho importante e significante, porém vivenciavam alto risco psicossocial no que se refere à exigência de atenção e exigência emocional das atividades desenvolvidas na unidade. Poucos estavam satisfeitos com o trabalho, com o ambiente e com a utilização das habilidades individuais pelo serviço. As informações sobre as relações psicossociais constituem um importante indicador para análise das situações de trabalho, gerando informações que apoiam intervenções seguras sobre o processo de trabalho.

Objective: To analyze the level of psychosocial risks of workers at the Central Sterile Supply Department of a large hospital in Rondônia. Method: Cross-sectional study, including assistants, nursing technicians, and nurses, using the Copenhagen Psychosocial Questionnaire. Descriptive analyses were performed using the Stata® statistical package, version 11. Results: 35 workers took part in the study, most of them women, aged over 40 years old, and nursing technicians. Of the six dimensions assessed, four had a medium risk. The dimension of justice and respect presented a high psychosocial risk, and the dimension of work organization and content, low risk. Conclusion: The workers considered their work important and significant, but they experienced a high psychosocial risk with regard to the demand for attention and emotional demand of the activities carried out in the unit. Few were satisfied with the work, the environment, and the use of individual skills by the service. Information about psychosocial relationships is an important indicator for analyzing work situations, generating information that supports safe interventions in the work process.

Objetivo: Analizar el nivel de riesgo psicosocial de los trabajadores del Centro de Material y Esterilización de un gran hospital de Rondônia. Método: Estudio transversal, incluyendo auxiliares, técnicos de enfermería y enfermeras, utilizando el Cuestionario Psicosocial de Copenhague. Los análisis descriptivos se realizaron con el paquete estadístico Stata® versión 11. Resultados: participaron 35 trabajadores, en su mayoría mujeres, mayores de 40 años y técnicos de enfermería. De las seis dimensiones evaluadas, cuatro tenían un riesgo medio. La dimensión de justicia y respeto presentó un alto riesgo psicosocial y la dimensión de organización y contenido del trabajo fue de bajo riesgo. Conclusión: Los trabajadores consideraron su trabajo importante y significativo, pero experimentaron un alto riesgo psicosocial en cuanto a la demanda de atención y demanda emocional de las actividades desarrolladas en la unidad. Pocos estaban satisfechos con el trabajo, el entorno y el uso de habilidades individuales por parte del servicio. La información sobre las relaciones psicosociales es un indicador importante para analizar situaciones laborales, generando información que sustente intervenciones seguras en el proceso laboral.

Diretrizes brasileiras para o manejo de potenciais doadores de órgãos em morte encefálica. Uma força-tarefa composta por Associação de Medicina Intensiva Brasileira, Associação Brasileira de Transplantes de Órgãos, Brazilian Research in Critical Care Network e Coordenação Geral do Sistema Nacional de Transplantes / Brazilian guidelines for the management of brain-dead potential organ donors. The task force of the Associação de Medicina Intensiva Brasileira, Associação Brasileira de Transplantes de Órgãos, Brazilian Research in Critical Care Network, and the General Coordination of the National Transplant System

RESUMO Objetivo: Fornecer recomendações para nortear o manejo clínico do potencial doador em morte encefálica. Métodos: O presente documento foi formulado em dois painéis compostos por uma força tarefa integrada por 27 especialistas de diferentes áreas que responderam a questões dirigidas aos seguintes temas: ventilação mecânica, hemodinâmica, suporte endócrino-metabólico, infecção, temperatura corporal, transfusão sanguínea, e uso de checklists. Os desfechos considerados foram: parada cardíaca, número de órgãos retirados ou transplantados e função/sobrevida dos órgãos transplantados. A qualidade das evidências das recomendações foi avaliada pelo sistema Grading of Recommendations Assessment, Development, and Evaluation. Resultados: Foram geradas 19 recomendações a partir do painel de especialistas. Dessas, 7 foram classificadas como fortes, 11 fracas e uma foi considerada boa prática clínica. Conclusão: Apesar da concordância entre os membros do painel em relação à maior parte das recomendações, o grau de recomendação é fraco em sua maioria.

Abstract Objective: To contribute to updating the recommendations for brain-dead potential organ donor management. Methods: A group of 27 experts, including intensivists, transplant coordinators, transplant surgeons, and epidemiologists, answered questions related to the following topics were divided into mechanical ventilation, hemodynamics, endocrine-metabolic management, infection, body temperature, blood transfusion, and checklists use. The outcomes considered were cardiac arrests, number of organs removed or transplanted as well as function / survival of transplanted organs. The quality of evidence of the recommendations was assessed using the Grading of Recommendations Assessment, Development, and Evaluation system to classify the recommendations. Results: A total of 19 recommendations were drawn from the expert panel. Of these, 7 were classified as strong, 11 as weak and 1 was considered a good clinical practice. Conclusion: Despite the agreement among panel members on most recommendations, the grade of recommendation was mostly weak.

First characterization of multixenobiotic activity in Collembola: An approach on cadmium-induced response.

ATP-binding cassette (ABC) efflux pumps mediate the activity of the Multixenobiotic Resistance (MXR) mechanism and have been proposed as a biomarker of environmental pollution mainly in aquatic invertebrates. MXR activity was never investigated in Collembola and represents a potential tool for soil biomonitoring. This study aimed to characterize for the first time the activity of ABC efflux pumps in the gut of collembolan species, and investigate its responsiveness to cadmium (Cd), a common stressor found in polluted soils. We performed in vitro rhodamine-B accumulation assays in the presence of model inhibitors of ABC efflux pumps: verapamil hydrochloride as P-gp (P-glycoprotein) inhibitor, and MK571, as MRPs (multidrug resistance-related proteins) inhibitor. We also performed rhodamine-B accumulation assays under Cd-exposure (209 µg/L;1 µM). Our results showed that all species presented basal (noninduced) level of MXR activity in their gut. Efflux pumps P-gp and/or MRPs activity were confirmed in Cyphoderus innominatus, Cyphoderus similis, and Folsomia candida, the standard species. The rhodamine-B accumulation assays performed with Cd, applied as soil pollutant, showed that the gut of non-standard species C. similis and Trogolaphysa sp. presented an increase of MXR activity for both P-gp and MRP transporters, indicating the potential of these species as test organisms for soil ecotoxicology studies in Neotropical region. Our findings suggest a functional role of ABC transporters in the collembolan gut and their cellular involvement in Cd defense response, corroborating that MXR phenotype in Collembola can be a promising tool for bioindication of soil contamination.

Factors influencing endothelial cell density of corneas for transplantation.

To evaluate factors affecting corneal endothelial cell density (ECD) under enucleation and preservation time studies at Eye Bank of the Federal District of Brazil. We conducted a case-control study collecting data from 1128 corneas where death-to-enucleation time and enucleation-to-preservation time were within 24 h. Low cell count were those corneas with an ECD less than 2000 cells/mm2 and high cell count was defined as those with ECD greater than 2000 cells/mm2. We calculated the independent risk factors related to: cause of death, donor age, death-to-enucleation time, enucleation-to-preservation time and primary graft failure. Correlation analysis was used to assess which parameters influence ECD: death-to-enucleation time, enucleation-to-preservation time, average cell area (AVE), coefficient of variation and percentage of hexagonal cells. Of the total number of corneas, 1004 had ECD data and were selected for the study. 87.4% (n = 877) had high cell counts with 2699 ± 412 cells/mm2. The mean donor age was 38.8 ± 16 years. The most common causes of death were external causes (48.6%, n = 488). Longer times from death-to-enucleation, up to 24 h were not associated with a decrease in ECD (OR 0.58; P = 0.44) or risk of graft survival (P = 0.74). Enucleation-to-preservation intervals greater than 12 h showed increased risk of graft survival (P = 0.04). AVE was the main parameter for ECD (R2 = 0.96, P < 0.001). The overall graft survival rate was 98.2% (n = 761). Donors with 40 years of age and above did not present a higher risk of graft survival (P = 0.09). We suggest that the maximum time from death-to-enucleation should be 24 h, assuming the body has been refrigerated after 6 h; and from enucleation-to-preservation time of 12 h, followed by proper processing and cornea morphology examination.

Evaluation of working conditions at a central sterile services department in northern Brazil.

Introduction: Environmental conditions and the work process in the Central Sterile Services Department expose workers to many hazards. Objectives: To analyze the working conditions that have an influence on the overall health of workers at a Central Sterile Services Department of a hospital in northern Brazil. Methods: This study used employed the ergonomic analysis of work. Three data collection tools were applied to characterize sociodemographic and occupational profiles. Furthermore, physical environmental hazards were analyzed using specific equipment. Descriptive and bivariate analyses were performed in Stata®13 software. Results: Thirty-five workers participated in the study, most of whom were women, aged above 40 years, and worked as nursing technicians. It became evident that workers were exposed to inappropriate lighting and to noises coming from autoclaves, from the central air conditioning, and from the use of medicinal gas. The risks for musculoskeletal injuries on spine, shoulders, and lower limbos were specifically related to overload resulting from the posture maintained for long periods. Female sex was associated with severe or excruciating pain" (p = 0.04). Conclusions: Sound, mechanical, and visual hazards were found. Most participants complained of musculoskeletal pain, and the cervical spine was the site with the most frequent reports of excruciating pain. These results point out to the need of a policy to improve the quality of work in the health care unit studied; however, these findings may also bring light to the problem in other institutions that have a physical structure similar to that found in this research.

Introdução: As condições ambientais e o processo de trabalho no Centro de Material e Esterilização expõem os trabalhadores a diversos riscos. Objetivos: Analisar as condições de trabalho que influenciam a saúde global dos trabalhadores do Centro de Material e Esterilização de um hospital do norte do Brasil. Métodos: Utilizou-se a metodologia de análise ergonômica do trabalho. Foram aplicados três instrumentos de coleta de dados para caracterizar os perfis sociodemográfico e ocupacional. Além disso, foram analisados os riscos físico-ambientais utilizando equipamentos específicos. As análises descritiva e bivariada foram realizadas no software Stata®13. Resultados: Participaram do estudo 35 trabalhadores, sendo a maioria mulheres, com idade acima de 40 anos e técnicos de enfermagem. Evidenciou-se que os trabalhadores eram expostos a iluminância inadequada e ruídos originados das autoclaves, da central do ar-condicionado e do uso do gás medicinal. Os riscos para lesões musculoesqueléticas na coluna, no ombro e nos membros inferiores especificamente se relacionam à sobrecarga exigida pelas posturas assumidas por longos períodos. O sexo feminino foi associado com dor do tipo "bastante ou extrema" (p = 0,04). Conclusões: Foram encontrados riscos sonoros, mecânicos e visuais. A maioria dos participantes apresentou queixas de dores musculoesqueléticas, sendo a coluna cervical o local de maior frequência de dor do tipo extrema. Esses resultados apontam para a necessidade de uma política de melhorias da qualidade do trabalho na unidade estudada; porém, esses achados também podem trazer luz à problemática em outras instituições que possuam estrutura física semelhante à encontrada nesta pesquisa.

Brazilian guidelines for the management of brain-dead potential organ donors. The task force of the AMIB, ABTO, BRICNet, and the General Coordination of the National Transplant System.

OBJECTIVE: To contribute to updating the recommendations for brain-dead potential organ donor management. METHOD: A group of 27 experts, including intensivists, transplant coordinators, transplant surgeons, and epidemiologists, joined a task force formed by the General Coordination Office of the National Transplant System/Brazilian Ministry of Health (CGSNT-MS), the Brazilian Association of Intensive Care Medicine (AMIB), the Brazilian Association of Organ Transplantation (ABTO), and the Brazilian Research in Intensive Care Network (BRICNet). The questions were developed within the scope of the 2011 Brazilian Guidelines for Management of Adult Potential Multiple-Organ Deceased Donors. The topics were divided into mechanical ventilation, hemodynamic support, endocrine-metabolic management, infection, body temperature, blood transfusion, and use of checklists. The outcomes considered for decision-making were cardiac arrest, number of organs recovered or transplanted per donor, and graft function/survival. Rapid systematic reviews were conducted, and the quality of evidence of the recommendations was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. Two expert panels were held in November 2016 and February 2017 to classify the recommendations. A systematic review update was performed in June 2020, and the recommendations were reviewed through a Delphi process with the panelists between June and July 2020. RESULTS: A total of 19 recommendations were drawn from the expert panel. Of these, 7 were classified as strong (lung-protective ventilation strategy, vasopressors and combining arginine vasopressin to control blood pressure, antidiuretic hormones to control polyuria, serum potassium and magnesium control, and antibiotic use), 11 as weak (alveolar recruitment maneuvers, low-dose dopamine, low-dose corticosteroids, thyroid hormones, glycemic and serum sodium control, nutritional support, body temperature control or hypothermia, red blood cell transfusion, and goal-directed protocols), and 1 was considered a good clinical practice (volemic expansion). CONCLUSION: Despite the agreement among panel members on most recommendations, the grade of recommendation was mostly weak. The observed lack of robust evidence on the topic highlights the importance of the present guideline to improve the management of brain-dead potential organ donors.

Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study).

BACKGROUND: The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest. METHODS/DESIGN: The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care). The primary outcome is loss of potential donors due to cardiac arrest. Secondary outcomes are the number of actual organ donors and the number of solid organs recovered per actual donor. Exploratory outcomes include the achievement of relevant clinical goals during the management of brain-dead potential organ donors. The present statistical analysis plan (SAP) describes all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of the trial. DISCUSSION: The SAP of the DONORS study aims to describe its analytic procedures, enhancing the transparency of the study. At the moment of SAP subsmission, 63 institutions have been randomised and were enrolling study participants. Thus, the analyses reported herein have been defined before the end of the study recruitment and database locking. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03179020. Registered on 7 June 2017.